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Recruiting NCT04475640

Cancer Genetic Testing in Ethnic Populations

No phase Interventional Breast Carcinoma Carcinoma of Unknown Primary Central Nervous System Carcinoma Digestive System Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biospecimen Collection, Genetic Testing.
Who it may be relevant to
Registry conditions: Breast Carcinoma, Carcinoma of Unknown Primary, Central Nervous System Carcinoma, Digestive System Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

GEMINI - Cancer Genetic Testing in Ethnic Populations

Overview

This clinical trial examines the integration of cancer genetic testing in various ethnic populations. Studying individuals and families at risk of cancer may help identify cancer genes and other persons at risk. The information from this study may provide an opportunity for cancer risk stratification and individualized screening in these ethnic populations.

Detailed description

PRIMARY OBJECTIVE:

I. To determine the prevalence of genetic mutations in cancer patients from various ethnic populations seeking care at Mayo Clinic Arizona and Mayo Clinic Florida cancer clinics.

SECONDARY OBJECTIVES:

I. Perform a chart review to assess the impact of genetic testing as part of standard of oncology care:

Ia. Determine prevalence of pathogenic germline mutation detected by multi-gene panel testing.

Ib. Determine differences in germline mutation detection in these patients as compared to traditional guideline (National Comprehensive Cancer Network \[NCCN\]) based approach for genetic evaluation.

OUTLINE:

Patients undergo collection of blood or saliva sample for genetic testing.

Interventions

  • Procedure Biospecimen Collection
    Undergo collection of blood sample
  • Other Genetic Testing
    Undergo genetic testing

Primary outcome measures

  • Prevalence of pathogenic germline mutations in enrolled patients within each cancer site [Time frame: Study completion (2 years)]
  • Prevalence of positive pathogenic germline mutations [Time frame: Study completion (2 years)]
  • Rate of mutation detection via genetic testing to clinical practice guidelines of traditional family history criteria [Time frame: Study completion (2 years)]
  • Impact of germline genetic testing on both therapeutic management and targeted cancer prevention [Time frame: Study completion (2 years)]

Eligibility criteria

Inclusion criteria

  • Patients at least 18 years of age
  • Individuals diagnosed with any solid tumor cancer including, but not limited to, gastrointestinal, breast, gynecological, genitourinary, skin, central nervous system (CNS)/brain, head/neck, musculoskeletal or cancer of unknown primary; and presenting to Mayo Clinic (MC Arizona or MC Florida) for clinical management/treatment; and patients receive genetic testing as described above
  • Self-identified as being from various ethnic populations including Hispanic/Latino, Native American/Alaskan, African American (including of African descent), Asian and other European populations
  • Blood collection is feasible (health, access and/or tolerability) for requested blood sample(s)
  • Individuals have agreed to participate and signed the study informed consent form

Exclusion criteria

  • Patients who have had prior germline genetic testing involving a 40+ gene panel within the last 24 months at Mayo Clinic and available for review by the research coordinator at time of consent
  • Past or current history of hematological cancer (including leukemias, multiple myeloma)
  • All bone marrow transplants

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

United States · 2 centers
  • Mayo Clinic in Arizona — Scottsdale
  • Mayo Clinic in Florida — Jacksonville

Identifiers

NCT: NCT04475640 · GEMINI · 19-006717

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗